A kind of interventional medical device
Technical field
The application relates to medical instruments field, particularly relates to a kind of interventional medical device.
Background technology
Interventional medical device is the emerging medical device technology of recent two decades, in the wound reducing patient, improves disease therapeuticing effect aspect and plays very important effect.For example, be applied in the various intraluminal intervention apparatus of human body, as intravascular stent, biliary tract rack, esophageal stents appear, intestinal support, stents of pancreatic duct, urethra rack or trachea bracket etc., and corresponding interposing catheter, sacculus, filter etc.Wherein, support is especially outstanding in the performance in interventional medical device field.In the angiopathy causing because of angiemphraxis or other reasons, support is proved to be a kind of relatively successfully interventional medical device of long-term implantable intravascular.When operation, support is transported to the obstruction diseased region of blood vessel by carrier, then releasing bracket, utilizes support to expand the vascular opening blocking, and makes the blood vessel blocking keep unimpeded.
For improving interventional medical device bio-compatible effect and therapeutic effect in vivo, can also be on these a certain parts of apparatus body or whole surface coated medicament and/or polymer.For example rack surface can apply the polymer coating that contains medicine, after the support implant into body that contains medication coat, not only can be by the vascular opening blocking, and on it, medication coat can also constantly discharge medicine to the lesion vessels tissue contacting with it, thereby reach the object of thorough healing.
Yet, due to the complexity of physiological make-up in body, the application of interventional medical device in human body, itself also exists the problem of complicated biocompatibility, when polymeric material is coated on interventional medical device in addition, equally also can there is in vivo the problem of biocompatibility.Conventional polymeric material mainly contains polymethacrylate polymer, fluoropolymer, polyethylene based polymers or polystyrene base polymer at present, and these polymer are commercial Application at the beginning of application, and biocompatibility is poor.
Therefore existing interventional medical device is after long-term implant into body, because biocompatibility causes comparatively serious thrombosis and post-operative complication compared with missionary society.
Summary of the invention
For solving the problems of the technologies described above, the embodiment of the present application provides a kind of interventional medical device, and technical scheme is as follows:
An interventional medical device, described interventional medical device outer surface is provided with at least one deck coating, and in described coating, the material of outermost layer coating is the polymer that contains sulfonic acid group.
Preferably, the thermoplastic elastomer (TPE) that the polymer that contains sulfonic acid group described in is sulfonation.
Preferably, the thermoplastic elastomer (TPE) of described sulfonation is sulfonated phenylethylene-olefin copolymer.
Preferably, described styrene-olefin copolymer is styrene-isobutene. diblock or triblock copolymer.
Preferably, in described styrene-isobutene. diblock or triblock copolymer, styrene weight percentage is 25%~55%.
Preferably, the sulphonation rate of the polymer that contains sulfonic acid group in described outermost layer coating is 5%~30%.
Preferably, the sulphonation rate of the polymer that contains sulfonic acid group in described outermost layer coating is 10%~20%.
In this interventional medical device, when described coating is multilamellar, layer coating material of other except outermost layer is the polymer that contains sulfonic acid group.
Preferably, the sulphonation rate of the polymer that contains sulfonic acid group in described other layer of coating except outermost layer is less than the sulphonation rate of the polymer that contains sulfonic acid group in outermost layer.
The sulphonation rate of the polymer that preferably, contains sulfonic acid group in described other coating except outermost layer is 0%~15%.
The sulphonation rate of the polymer that preferably, contains sulfonic acid group in described other coating except outermost layer is 5%~10%.
Preferably, in described coating, at least one deck contains medicine.
In this interventional medical device, when described medicine with described in contain sulfonic acid group polymer while reacting, described in contain medicine the material of coating do not adopt the polymer that contains sulfonic acid group.Preferably, described in contain medicine coating and the polymer coating that contains sulfonic acid group between have one deck sealing coat at least, the material of described sealing coat does not adopt the polymer that contains sulfonic acid group.
Preferably, described interventional medical device is stent for human body lumens.
Preferably, described stent for human body lumens comprises: coronary artery stent, intracranial vessel support, peripheral blood vessel support, art medium-height trestle, heart valve bracket, biliary tract rack, esophageal stents appear, intestinal support, stents of pancreatic duct, urethra rack or trachea bracket.
The interventional medical device that the embodiment of the present application provides, its outermost layer coating material is the polymer that contains sulfonic acid group, surface characteristic that polymer is identical with heparin and suitable hydrophilic have been given in the existence of this sulfonic acid group.After this interventional medical device implant into body, under body fluid environment, the existence of material surface sulfonic acid group, not only makes material can form the hydrophilic film of skim molecular level, and surface band negative charge, strengthens with cell compatibility.
Therefore, after this interventional medical device implant into body, outermost layer has cell close friend's surface, and cell is easily in its surperficial adherent growth, but also has the surface characteristic identical with heparin, can suppress the formation of thrombosis, reduces the incidence rate of post-operative complication.
In addition, in this polymer that contains sulfonic acid group, also contain lipophilic main chain, can to reach molecular level compatible with medicine, so the polymer coating that contains sulfonic acid group of this interventional medical device can also carry bioactive medicine, and can control the slow release of medicine, improve therapeutic effect.
Accompanying drawing explanation
In order to be illustrated more clearly in the embodiment of the present application or technical scheme of the prior art, to the accompanying drawing of required use in embodiment or description of the Prior Art be briefly described below, apparently, the accompanying drawing the following describes is only some embodiment that record in the application, for those of ordinary skills, do not paying under the prerequisite of creative work, can also obtain according to these accompanying drawings other accompanying drawing.
The structural representation of a kind of interventional medical device that Fig. 1 provides for the embodiment of the present application one;
The structural representation of a kind of interventional medical device that Fig. 2 provides for the embodiment of the present application two;
The structural representation of a kind of interventional medical device that Fig. 3 provides for the embodiment of the present application three;
The structural representation of a kind of interventional medical device that contains medicine that Fig. 4 provides for the embodiment of the present application four;
The structural representation of the interventional medical device that the another kind that Fig. 5 provides for the embodiment of the present application four contains medicine;
Fig. 6 is the polymer that contains sulfonic acid group and the polymer controls medicine-releasing performance comparison diagram that does not contain sulfonic acid group.
The specific embodiment
A kind of interventional medical device that the embodiment of the present application provides, the material of its outermost layer polymer coating is to have the hydrophilic polymer that contains sulfonic acid group, after implant into body, at the outer surface of this interventional medical device, can form the friendly layer of cellular environment with cytocompatibility, thereby cell is easily in its surperficial adherent growth, and this surface also has the surface characteristic identical with heparin, can suppress the formation of thrombosis, reduce the generation of complication.
It is more than the application's core concept, in order to make those skilled in the art person understand better the technical scheme in the application, below in conjunction with the accompanying drawing in the embodiment of the present application, technical scheme in the embodiment of the present application is clearly and completely described, obviously, described embodiment is only the application's part embodiment, rather than whole embodiment.Embodiment based in the application, those of ordinary skills are not making all other embodiment that obtain under creative work prerequisite, all should belong to the scope of the application's protection.
Embodiment mono-:
The structural representation of a kind of interventional medical device that Fig. 1 provides for the embodiment of the present application one.
As shown in Figure 1, this interventional medical device comprises rack body 1 and the coating 2 that is arranged on rack body 1 outer surface, wherein: the material of coating 2 is the polymer that contains sulfonic acid group.
The embodiment of the present application, the polymer that contains sulfonic acid group that coating 2 is used is including, but not limited to the thermoplastic elastomer (TPE) of sulfonation, be preferably sulfonated phenylethylene-olefin copolymer, more preferably styrene-isobutene. diblock or triblock copolymer, and wherein styrene weight percentage is 25~55%.In addition the thermoplastic elastomer (TPE) of this sulfonation can also be other copolymer well known to those of ordinary skill in the art.
The embodiment of the present application, the sulphonation rate in the polymer that contains sulfonic acid group that coating 2 is used is preferably 5%~30%, because the introduction volume of sulfonic acid group (being the content of sulfonic acid group) is very large to the performance impact of copolymer material in copolymer.Sulfonic acid group introduction volume uses sulphonation rate (having the phenyl ring of how much percentage ratio to be sulfonated) to characterize conventionally, take polystyrene butylene copolymer as example, and when sulphonation rate is greater than 50%, material just can follow the string and film property; When sulphonation rate is greater than 30%, the insufficient strength of material, adhesion is also poor.So in the embodiment of the present application, sulphonation rate in the polymer that contains sulfonic acid group is 5%~30%, within the scope of this, the polymer-coated that contains sulfonic acid group on rack body 1 after, coating is not easy to crack when stressed, peel off, and physical property meets the demands.In the embodiment of the present application, the sulphonation rate in the polymer that contains sulfonic acid group that coating 2 is used more preferably 10%~20%.
The embodiment of the present application, the human lumen support that this interventional medical device is well known to those skilled in the art, including, but not limited to: coronary artery stent, intracranial vessel support, peripheral blood vessel support, art medium-height trestle, heart valve bracket, biliary tract rack, esophageal stents appear, intestinal support, stents of pancreatic duct, urethra rack or trachea bracket, be preferably coronary artery stent.
Embodiment bis-:
The structural representation of a kind of interventional medical device that Fig. 2 provides for the embodiment of the present application two.
As shown in Figure 2, this interventional medical device comprises rack body 1, is coated in outermost layer coating 2 and the internal layer coating 3 of rack body 1 outer surface, wherein: the material of outermost layer coating 2 is the polymer that contains sulfonic acid group, and the sulphonation rate in the polymer that contains sulfonic acid group that outermost layer coating 2 is used is 5%~30%, more preferably 10%~20%.
The material of internal layer coating 3 can be inorganic coating, organic coating or traditional polymer coating, can also be for containing the polymer coating of sulfonic acid group, when the material of internal layer coating 3 is the polymer that contains sulfonic acid group, because internal layer coating 3 is different from the residing environment of outermost layer coating 2, so require also different to material behavior, need the adhesion property of material stronger, so contain the sulphonation rate that the sulphonation rate of the polymer of sulfonic acid group is less than the polymer that contains sulfonic acid group in outermost layer coating 2 in internal layer coating 3, in the embodiment of the present application, the sulphonation rate that contains the polymer of sulfonic acid group in internal layer coating 3 should be controlled at below 15%, be preferably 5~10%.
Embodiment tri-:
The structural representation of a kind of interventional medical device that Fig. 3 provides for the embodiment of the present application three.
As shown in Figure 3, on the basis of embodiment bis-, can also between internal layer coating 3 and rack body 1, increase one deck primer coating 4 as required.
The same with the internal layer coating 3 in embodiment bis-, the material of primer coating 4 can be inorganic coating, organic coating or traditional polymer coating equally, can also be for containing the polymer coating of sulfonic acid group.When the material of primer coating 4 is the polymer that contains sulfonic acid group, the sulphonation rate that contains the polymer of sulfonic acid group in primer coating 4 should be controlled at below 15%, is preferably 5~10%.
Embodiment tetra-:
The embodiment of the present application, rack body 1 outer surface is provided with laminated coating, wherein: the material of outermost layer coating is the polymer that contains sulfonic acid group, and the sulphonation rate in the polymer that contains sulfonic acid group that outermost layer coating 2 is used is 5%~30%, more preferably 10%~20%, and at least in one deck coating, contain medicine in laminated coating.
As shown in Figure 4, in the embodiment of the present application, the outer surface of support 1 is coated with three layers of coating, is respectively outermost layer coating 2, internal layer coating 3 and primer coating 4, wherein: internal layer coating 3 contains medicine.
In other embodiment of the application, in order to prevent that the polymer that contains sulfonic acid group in some specific medicine and outermost layer coating 2 from reacting, between the internal layer coating that contains medicine and outermost layer, be also provided with sealing coat 5 as shown in Figure 5, and the material of the internal layer coating 3 that contains medicine can not adopt the polymer that contains sulfonic acid group.
The embodiment of the present application, the active medicine that the medicine containing in coating is well known to those skilled in the art, including, but not limited to anticoagulant, cancer therapy drug, microorganism immunosuppressant, hormone and/or other anti-angiogenic restenosis medicaments, be preferably rapamycin.
The interventional medical device that the embodiment of the present application provides, the material of its outermost layer coating is the polymer that contains sulfonic acid group.The existence of this sulfonic acid group, makes polymer have the surface characteristic identical with heparin and suitable hydrophilic.After this interventional medical device implant into body, under body fluid environment, the surface of interventional medical device not only can form one deck water-wetted surface, and with negative charge, strengthens with cell compatibility, and cell is easily in its surperficial adherent growth; And its surface characteristic identical with heparin, also give the anticoagulation function of material excellence, thereby can suppress the formation of thrombosis, reduce the incidence rate of post-operative complication.
In addition, in this polymer, also contain lipophilic main chain, can to reach molecular level compatible with medicine, as shown in Figure 6, be the polymer that contains sulfonic acid group and the polymer controls medicine-releasing performance comparison diagram that does not contain sulfonic acid group.In figure, the material of 1 curve is not for containing the polymer of sulfonic acid group, the material of n curve is that sulphonation rate is 5% the polymer that contains sulfonic acid group, the material of m curve is that sulphonation rate is 25% the polymer that contains sulfonic acid group, in figure, can draw, the polymer coating that contains sulfonic acid group of this interventional medical device, can also carry bioactive medicine, and can control the slow release of medicine, improve therapeutic effect.
The explanation of above embodiment is just for helping to understand method of the present invention and core concept thereof.It should be pointed out that for those skilled in the art, under the premise without departing from the principles of the invention, can also carry out some improvement and modification to the present invention, these improvement and modification also fall in the protection domain of the claims in the present invention.